Evaluating surgical outcomes for patients with malocclusion using a Surgery First approach and aligners
Official title: Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
Run by Rio de Janeiro State University · NCT05822271 · Data updated 2026-11-12
This study is testing whether a Surgery First approach using braces or clear aligners can improve the quality of life and treatment results for patients with a specific type of jaw misalignment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 17 Years to 35 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Rio de Janeiro State University Academic / other |
| Locations | 1 site (Rio de Janeiro) |
| Status | Recruiting |
| Started | January 30, 2022 |
| Main results expected | August 2025 |
| Study ends | October 2025 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT05822271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with skeletal malocclusion requiring bimaxillary surgery and specific angular measurements indicating a need for surgical intervention.
✕Probably not a fit
Patients with previous orthodontic treatment, craniofacial anomalies, or other specific exclusions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study aims to compare the treatment outcomes and quality of life for skeletal Class III patients who undergo a Surgery First approach using either conventional fixed appliances or aligners. The study will collect data through validated questionnaires, including the Orthognathic Quality of Life Questionnaire and the Oral Health Impact Profile, to assess the impact of the treatment on patients' lives. By analyzing these outcomes, the study seeks to determine the effectiveness of the Surgery First approach in improving both aesthetic and functional results for patients with specific skeletal malocclusions.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with skeletal Class III malocclusion, potentially improving their quality of life.
How similar studies have gone: While the Surgery First approach is gaining attention, this specific comparison with aligners is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults; * Skeletal malocclusion; * ANB Angle zero or negative; * Witts negative; * Etiology: mandibular excess, a maxillary deficiency, or a combination of both; * Indication for bimaxillary surgery; Exclusion Criteria: * Previous orthodontic treatment; * Craniofacial anomaly or previous fracture of the facial bones; * Total edentulism; * Deep curve of Spee; * Vertical asymmetry; * Any medication use that contraindicates surgical treatment.
Where it's running
-
Rio de Janeiro State University
Rio de Janeiro, Brazil Recruiting
Study contacts
- Study coordinator: Arthur Cunha, MSc
- Email: cunhas.arthur@gmail.com
- Phone: 55-21-967637007
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.